Identity
- Trade Name
- C1-5-RS EUDAMEDNA FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- C1-5-RS EUDAMED
- Model / Reference
- 5384874 EUDAMEDH40462LA EUDAMEDC1-5-RS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682110952 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00223H2 EUDAMED
- Direct Marketing DI
- 00840682110952 EUDAMED
- 510(k) Number
- K160184 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
C1-5-Rs by GE Healthcare Japan Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00223H2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Japan Corporation
- EUDAMED SRN
- JP-MF-000009291
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 355f4940-3a05-4ede-948d-d4fcee11f10c 61 fields · synced Jul 20, 2026
- FDA UDI 8b454105-5eec-4650-8f99-8e8d87a4aefe 34 fields · synced May 24, 2026